How to obtain a CE mark for your medical device under the upcoming EU regulations
Kolabtree's Sophie Laurenson discusses how manufacturers should go about gaining a CE mark for their medical devices under…
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17 Feb 21
Kolabtree's Sophie Laurenson discusses how manufacturers should go about gaining a CE mark for their medical devices under…
Last month, the FDA introduced a five-point action plan to help integrate AI- and ML-powered technologies into the…
In the past week, the WHO, Canada and Japan have also criticised export restrictions introduced by the EU…
22 Jan 21
MedTech Europe has recommended several of the changes made to digital health regulation in Europe during the pandemic…
Jamie Bell speaks to the BSI's Gary Slack to find out how auditing and other means of medical…
15 Jan 21
Global law firm Morgan Lewis released a set of predictions for medical device manufacturers explaining how a Biden…
A new FDA action plan regarding AI involves further development of proposed regulatory frameworks and fostering a patient-centred…
In 2022, the long-standing IVDD will be replaced by the IVDR, ushering in a new era regarding how…
The UK recently adopted the GMDN classification system as part of its new medical device database, which came…
The FDA has stated that, while face masks may need to be worn during MRI scans due to…